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NCT06268860Recruiting

A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants

A Phase 1 Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects
AmgenPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Atopic Dermatitis
Drug/Device/Intervention
Rocatinlimab vial injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Amgen
Location
Daytona Beach,Dallas,Madison,Leeds, United Kingdom,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Feb 15, 2024
End date
Aug 19, 2024
Enrollment
230 participants
Primary outcome

Maximum Observed Serum Concentration (Cmax) of Rocatinlimab,Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab,AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab

Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab
 given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy
 participants.

ICD-10 classifications
Atopic dermatitisAtopic dermatitis, unspecifiedOther atopic dermatitisAcute atopic conjunctivitisAllergic contact dermatitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06268860
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06268860 through Pure Global AI's free database. This Phase 1 trial is sponsored by Amgen and is currently Recruiting. The study focuses on Atopic Dermatitis. Target enrollment is 230 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.